MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Atrial Fibrillation (1729); Pancreatitis (4481); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/12/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "risk factors for eus-guided radiofrequency ablation adverse events in patients with pancreatic neoplasms: a large national french study (rafpan study)." literature summary: this retrospective study aimed to evaluate the safety profile of eus-rfa in a large population of patients with pancreatic neoplasms.A total of 100 patients were enrolled.A median of 3 shots (iqr, 2-4) were administered per session, with a radiofrequency power of 50 w used in all cases.The cumulative median ablation duration was 25 seconds (iqr, 15-39).Complete response was observed in 57 patients (58.2%), partial response in 32 (32.7%), and no response in 9 (9.2%).At the end of the radiologic follow-up (12 months [iqr, 6-16)), 59 patients (60.2%) achieved a complete tumor response, 31 (31.6%) a partial response, and 9 (9.2%) achieved no response.On univariate analysis, tumor size <20 mm (or, 4.61; 95% ci, 1.69-13.48; p =.004), nen pathology (or, 11.88; 95% ci, 2.71-73.27; p =.001).Multivariate analysis identified tumor size <20 mm (or, 5.26; 95% ci, 2.17-14.29; p <.001) and nen pathology (or, 7.95; 95% ci, 1.66-51.79; p <.001) as factors independently related to complete response.Among 116 eus-rfa sessions, 22 patients (19.0%) reported an adverse event (ae).One periprocedural atrial fibrillation resolved spontaneously a few hours after the procedure and required no intervention or prolonged hospitalization.Twenty-one pancreatic aes were observed: 7 patients presented epigastric pain with no serum enzyme elevation, 11 patients had pancreatitis (6 mild, 3 moderate, 2 severe), and 3 patients had main pancreatic duct (mpd) leak with no pain or enzyme elevation.Overall, 8 aes were grade i, 11 were grade ii, and 3 were grade iiia.At the end of follow-up, 3 patients (3.0%) developed mpd stricture with chronic pancreatitis above the stricture.No patients developed diabetes mellitus (table 2).No eus-rfa¿related mortality was observed.Nineteen aes required no interventions, and patients received medical treatment.Three patients (3.0% of the entire population) required endoscopic interventions: 2 eus pseudocyst drainages and 1 biliary and pancreatic stent placement.Interestingly, among 22 patients who reported an ae, 19 required only medical treatments and 3 were managed with endoscopic interventions (eus-guided pseudocyst drainage in 2 cases and pancreatic and biliary stent placement in 1 case).The results of this large study confirm an overall acceptable safety profile for pancreatic eus-rfa.Close proximity ( =1 mm) to the main pancreatic duct represents an independent risk factor for aes.Type of adverse events/number of patients: adverse events (22) (mild{13}, moderate{7}, severe{2}: these include the following events: pancreatic aes, atrial fibrillation), main pancreatic duct stricture with chronic pancreatitis (3).This was a large national french study that 20 centers agreed to participate.There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

Health effect - clinical code 4581 is used to code for main pancreatic duct (mpd) leak and mpd stricture.The suspect device has not been returned to olympus.Additional information has been requested but no information could be provided at this time.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17949764
• MDR Text Key: 325849585
• Report Number: 3002808148-2023-11395
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention